STRKYER KNEE AUGMENTATION GRAFT
FDA premarket approval P850054 · decided 1988-12-30
Approval details
- PMA number
- P850054
- Trade name
- STRKYER KNEE AUGMENTATION GRAFT
- Generic name
- LIGAMENTS AND TENDONS, SYNTHETIC
- Applicant
- Meadox Medicals, Div. Boston Scientific Corp.
- Date received
- 1985-08-05
- Decision date
- 1988-12-30
- Days to decision
- 1243 days
- Decision code
- APWD
- Product code
- LML
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Oakland, NJ
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING (K953647) | Meadox Medicals, Div. Boston Scientific Corp. | 1997-05-16 |
| MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT (K960766) | Meadox Medicals, Div. Boston Scientific Corp. | 1997-03-19 |
| MEADOX EXXCEL EPTFE VASCULAR GRAFT (K962433) | Meadox Medicals, Div. Boston Scientific Corp. | 1997-03-17 |
| HEMASHIELD VANTAGE (VASCULAR GRAFT (K961847) | Meadox Medicals, Div. Boston Scientific Corp. | 1997-01-22 |
| HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH (K962342) | Meadox Medicals, Div. Boston Scientific Corp. | 1996-09-10 |
| MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GRAFT (K955460) | Meadox Medicals, Div. Boston Scientific Corp. | 1996-05-30 |
| NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER (K952884) | Meadox Medicals, Div. Boston Scientific Corp. | 1996-02-21 |
| HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC (K955349) | Meadox Medicals, Div. Boston Scientific Corp. | 1996-02-14 |